"Platelet Rich Plasma for the Management of Post-Viral Olfactory Dysfunction.

Thomas Jefferson University

Status: Invitation-only

Conditions: Olfaction Disorders; Olfactory Disorder

Treatments: Other: Platelet rich plasma; Other: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT05666492

22D.470

Details and patient eligibility

About

SARS COV-19 has resulted in prolonged olfactory dysfunction in many patients. The investigators aim to compare the effect of topical platelet-rich plasma (test) vs saline (placebo) in patients with covid-related post-viral olfactory dysfunction.

Full description

The investigators hypothesize that the use of topical PRP will improve smell identification, threshold, and smell-related quality of life in comparison to a placebo.

This study will provide critical information for a promising new treatment of olfactory dysfunction with the highest level of evidence, in a randomized, placebo-controlled trial. Preliminary results from an ongoing pilot study investigating topical PRP is the basis for the hypothesis.

By investigating the efficacy of topical PRP in smell restoration, the investigators will provide a less-invasive way to deliver this autologous product. A randomized trial will set a precedent for the use of this treatment to serve a growing population of patients affected with post-COVID olfactory dysfunction. Over a period of one year, participants with post-viral olfactory dysfunction will be randomly assigned to a test or control group and will visit the clinic monthly for three months to receive PRP or saline based on their randomized group. This will be followed by 9 months of at-home electronic visits. At each visit both the test and control groups will undergo smell testing and will fill quality of life questionnaire.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients suffering from either post-viral or post-COVID smell loss of any duration, without a history of nasal surgery, nasal polyposis, chronic rhinosinusitis, or intranasal tumors
• Patients who are post-COVID must report at least a positive home test on history
• Patients with post-viral etiology must have recall of a viral illness that immediately preceded smell loss

Exclusion criteria

• History of olfactory dysfunction predating COVID-19 infection
• History of trauma, previous surgery, or obstructive cause of OD (nasal polyps, chronic rhinosinusitis)
• Pregnancy
• Patients who are unable to provide consent
• Patients with known bleeding disorders
• Patients with known malignancies

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 4 patient groups, including a placebo group

Less than 12 months PRP- Test

Experimental group

Description:

Patients randomized into the less than 12 months PRP arm will receive 3 doses of topical PRP each month apart and their sense of smell will be assessed during each visit followed by a monthly remote assessment of smell from home.

Treatment:

Other: Platelet rich plasma

Less than 12 months placebo- control

Placebo Comparator group

Description:

Patients randomized into the less than 12 months placebo arm will receive saline topically every month apart and their sense of smell will be assessed during each visit followed by a monthly remote assessment of smell from home.

Treatment:

Other: Saline

More than 12 months PRP- Test

Experimental group

Description:

Patients randomized into more than 12 months PRP arm will receive 3 doses of topical PRP each month apart and their sense of smell will be assessed during each visit followed by a monthly remote assessment of smell from home.

Treatment:

Other: Platelet rich plasma

More than 12 months Placebo- Control

Placebo Comparator group

Description:

Patients randomized into the less than 12 months placebo arm will receive saline topically every month apart and their sense of smell will be assessed during each visit followed by a monthly remote assessment of smell from home.

Treatment:

Other: Saline